Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase IV, randomised, open-label, multi-centre study to assess the impact on disease control, safety, patient and clinician experience of changing patients with advanced prostate cancer from a 3-monthly LHRH agonist to 6-monthly injections of Decapeptyl® SR 22.5 mg

    Summary
    EudraCT number
    		 2011-004213-16
    Trial protocol
    		 GB  
    Global end of trial date
    06 Feb 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 May 2025
    First version publication date
    25 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data validation only

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A-97-52014-181
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01673984
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Limited
    Sponsor organisation address
    190 Bath Road, Slough, Berkshire, United Kingdom, SL1 3XE
    Public contact
    Medical Director, Uro-Oncology, Ipsen Limited, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Uro-Oncology, Ipsen Limited, clinical.trials@ipsen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of Decapeptyl® SR 22.5 mg compared with a standard 3-monthly LHRH agonist in maintaining biochemical castration (STT level ≤0.5 ng/mL, changed to STT level <0.5 ng/mL to be in accordance with the European Association of Urology [EAU] Guideline) after 6 months of treatment.
    Protection of trial subjects
    The study and the archiving of essential documents were performed in compliance with Good Clinical Practices (GCP) and in accordance with the Declaration of Helsinki. The currently preferred such agents are LHRH agonists such as triptorelin (Decapeptyl® Sustained Released [SR]), which have an established and favourable benefit-risk profile, are convenient and many practitioners like the reversibility of the treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1
    From 65 to 84 years
    18
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 35 subjects screened and 27 subjects were enrolled. Following enrollment, 21 patients were randomised before the study was prematurely discontinued.

    Pre-assignment
    Screening details
    		 [Not Specified]

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Decapeptyl® SR 22.5 mg
    Arm description
    		 Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Decapeptyl® SR
    Investigational medicinal product code
    Other name
    Triptorelin pamoate
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).

    Arm title
    		 Current 3-monthly LHRH Agonist
    Arm description
    		 One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Decapeptyl SR® 11.25 mg
    Investigational medicinal product code
    Other name
    Triptorelin pamoate
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall.

    Number of subjects in period 1
    		Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Started
    14
    7
    Completed
    4
    1
    Not completed
    10
    6
         Study termination
    9
    6
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Decapeptyl® SR 22.5 mg
    Reporting group description
    		 Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).

    Reporting group title
    Current 3-monthly LHRH Agonist
    Reporting group description
    		 One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall.

    Reporting group values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist Total
    Number of subjects
    		 14 7 21
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 77.2 ( 5.4 ) 78.7 ( 9.3 ) -
    Gender categorical
    Units: Subjects
        Male
    		 14 7 21
    Employment status/Occupation
    Units: Subjects
        Employed
    		 2 1 3
        Retired
    		 12 6 18

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Decapeptyl® SR 22.5 mg
    Reporting group description
    		 Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).

    Reporting group title
    Current 3-monthly LHRH Agonist
    Reporting group description
    		 One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall.

    Primary: Percentage of Participants Maintaining Biochemical Castration

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining Biochemical Castration [1]
    End point description
    Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment. Analysis based on intent-to-treat (ITT) population comprised of 21 patients.
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis was presented.
    End point values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Number of subjects analysed
    14
    7
    Units: Percentage of participants
        number (not applicable)
    92.9
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment
    End point description
    Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation. Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Number of subjects analysed
    9
    4
    Units: Percentage of participants
        number (not applicable)
    22.2
    25
    No statistical analyses for this end point

    Secondary: Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels

    		 Close Top of page
    End point title
    		 Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels
    End point description
    Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value. Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.
    End point type
    Secondary
    End point timeframe
    6 and 12 months
    End point values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Number of subjects analysed
    13
    7
    Units: Percentage of participants
    number (not applicable)
        6 months (n = 13, 7)
    84.6
    100
        12 months (n = 2, 1)
    50
    100
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire

    		 Close Top of page
    End point title
    		 Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire
    End point description
    The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine). Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Number of subjects analysed
    3
    2
    Units: Units on a scale
        arithmetic mean (confidence interval 95%)
    71.7 (40.4 to 102.9)
    70.0 (-57.1 to 197.1)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)

    		 Close Top of page
    End point title
    		 Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)
    End point description
    TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all. Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.
    End point type
    Secondary
    End point timeframe
    6 and 12 month
    End point values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Number of subjects analysed
    14
    7
    Units: units on a scale
    arithmetic mean (confidence interval 95%)
        Baseline to 6 months - Effectiveness (n= 13, 7)
    3.2 (-12.5 to 18.9)
    13.1 (-10.8 to 37.0)
        Baseline to 12 months - Effectiveness (n= 3, 2)
    -33.3 (-74.7 to 8.1)
    -12.5 (-383.1 to 358.1)
        Baseline to 6 months - Side Effects (n= 13, 7)
    -2.6 (-12.9 to 7.8)
    4.8 (-6.0 to 15.5)
        Baseline to 12 months - Side Effects (n= 3, 2)
    -25.0 (-115.2 to 65.2)
    12.5 (-146.3 to 171.3)
        Baseline to 6 months - Convenience (n= 13, 7)
    4.7 (-6.3 to 15.7)
    2.0 (-9.8 to 13.7)
        Baseline to 12 months - Convenience (n= 3, 2)
    -1.9 (-36.6 to 32.9)
    2.8 (-103.1 to 108.7)
        Baseline to 6months -Global Satisfaction(n= 12, 6)
    -0.7 (-15.9 to 14.5)
    -4.2 (-11.5 to 3.2)
        Baseline to 12months -Global Satisfaction(n= 2, 2)
    -12.5 (-171.3 to 146.3)
    4.2 (-48.8 to 57.1)
    No statistical analyses for this end point

    Secondary: Patient Satisfaction With Treatment

    		 Close Top of page
    End point title
    		 Patient Satisfaction With Treatment
    End point description
    Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire. No participant analysis as no data was collected due to low number of participants recruited in the study.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - No data was collected due to low number of participants recruited in the study.
    [3] - No data was collected due to low number of participants recruited in the study.
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Changed Injection Frequency After Completion of the Study

    		 Close Top of page
    End point title
    		 Percentage of Participants who Changed Injection Frequency After Completion of the Study
    End point description
    Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Decapeptyl® SR 22.5 mg Current 3-monthly LHRH Agonist
    Number of subjects analysed
    5
    3
    Units: percentage of participants
        number (not applicable)
    80
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Decapeptyl® SR 22.5mg
    Reporting group description
    		 Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).

    Reporting group title
    Current 3-monthly LHRH Agonist
    Reporting group description
    		 One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall.

    Serious adverse events
    		 Decapeptyl® SR 22.5mg Current 3-monthly LHRH Agonist
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Decapeptyl® SR 22.5mg Current 3-monthly LHRH Agonist
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 14 (85.71%)
    7 / 7 (100.00%)
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Hot flush
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gait disturbance
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Suprapubic pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Penile pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Prostatitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    3 / 14 (21.43%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Productive cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Serum ferritin increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Laceration
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Cardiac disorders
    Bundle branch block right
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    5 / 14 (35.71%)
    0 / 7 (0.00%)
         occurrences all number
    5
    0
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Hemiparesis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Deafness
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Colitis microscopic
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Glossodynia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Micturition urgency
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Muscle atrophy
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Ear infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Eye infection bacterial
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Viral infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Lobar pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gout
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Jun 01 00:33:29 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA